Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and ...

Cellares, the contract drugmaker known for its cell therapy factory-in-a-box, will expand its operations to Europe after ...

Akadeum Life Sciences, the leader in buoyant microbubble cell separation, today announced that its Chief Executive Officer Brandon McNaughton, PhD, will present at Biotech Showcase (TM) 2026 in San ...

Single-use systems streamline CGT manufacturing by reducing cleaning validation and enabling quick changeovers, essential for ...

Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, ...

Autolus Therapeutics is working with Cellares to assess automated CAR T manufacturing to support rising demand for its ...

The first half of 2025 has been a notable one for Cellares. The cell therapy manufacturer operates its first commercial-scale Integrated Development and Manufacturing Organization Smart Factory in ...

- Joint venture will aim to develop a cell therapy manufacturing platform through robotics and will offer access to startups and academic institutions - In the pharmaceutical industry, the ...

The AMT designation gives Cellares’ clients using the Cell Shuttle priority review with the FDA leading to accelerated regulatory filings SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellares, the ...

CAR-T therapy is a major advance in cancer care, but high costs and centralized global manufacturing limit access.

We spoke with Scott Jones, PhD, SVP & CSO at BioBridge Global (BBG) to understand the challenges of product-specific potency ...